Incidence Of Metabolic Acidosis Research Articles

Improving Admission Temperature in Infants ≥34 Weeks' Gestation: A Quality Improvement Initiative.

NICU admission for hypothermia is a problem worldwide, with associated morbidity, mortality, and financial costs. Many interventions have been studied for smaller infants, but there has been little focus on infants born ≥34 weeks' gestational age (GA), though most deliveries occur at this gestation. Our primary aim was to improve the proportion of infants ≥34 weeks' GA with normal NICU admission temperature. Secondary outcomes included improvement of the proportion of normal first temperature in all infants ≥34 weeks' GA, independent of NICU admission, and improvement of predefined outcome measures. We completed a root cause analysis, using fishbone and process mapping to determine what factors were contributing to hypothermia. A series of changes were trialed using plan-do-study-act cycles to develop a standard operating procedure, covering both vaginal and cesarean section births. Outcome measures were analyzed using a P-chart as well as traditional statistical tests. We successfully increased the proportion of infants ≥34 weeks' GA with normothermia on NICU admission from 62% to 80% without increasing hyperthermia. In addition, the interventions improved the proportion of delivery room normothermia in all infants born ≥34 weeks' GA and were associated with a decreased need for intravenous therapy for hypoglycemia and the incidence of metabolic acidosis. This quality improvement initiative was successful at improving our institution's rates of normal infant temperature. The methodology used can be applied to other similar centers to improve this common problem.

Metabolic acidosis in patients with diabetes 2 undergoing cardiac surgery: The impact of SGLT2 inhibitor use: a retrospective cohort study.

Sodium-glucose cotransporter 2 inhibitors (SGLT2-i) lower blood sugar and reduce cardiovascular events and kidney failure. However, there have been increasing reports of euglycaemic diabetic ketoacidosis (eDKA) linked to SGLT2-i medicines. Investigating the association between SGLT2-i use and the incidence of metabolic acidosis in patients with type 2 diabetes undergoing cardiac surgery. A retrospective observational cohort study comprising 121 patients, with 38 in the SGLT2-i group and 83 in the control group. A 2-year period at Haukeland University Hospital, a tertiary regional hospital in Western Norway. Patients with type 2 diabetes undergoing cardiac surgery. Collection of clinical and laboratory data, including acid/base balance parameters, surgery details and SGLT2-i use. Base excess and anion gap measurements as indicators of ketosis development. A subgroup analysis in patients without renal failure (glomerular filtration rate > 60 ml min-1 m-2). Lower base excess levels and increased anion gaps were observed in the SGLT2-i group compared with controls at various time points postoperatively, with no significant differences in serum lactate levels.Twelve hours postoperatively, 41% of SGLT2-i patients without renal failure had a base excess -3 mmol l-1 or less after correction for serum lactate (indicating ketosis) compared with only 8% in the control group (P < 0.001). The anion gap was elevated in the SGLT2-i group compared to the control group at 12 h postoperatively (P = 0.018).Multivariable regression analysis identified SGLT2-i use as an independent factor associated with a lower base excess after correction for lactate levels (P < 0.001). Cessation of SGLT2-i medication did not correlate with the degree of acidosis. While taking SGLT2 inhibitors, diabetic patients undergoing heart surgery are at an increased risk of ketosis and possibly metabolic acidosis. This emphasises the importance of careful observation and effective treatment strategies within this group.

Laboratory features in acute paediatric poisoning with liquid laundry detergent capsules: a seven-year retrospective study in Romania

Introduction The epidemiological and clinical characteristics of acute poisoning with liquid laundry detergent capsules have been comprehensively reported. However, studies of laboratory test results in these exposures are uncommon. This study analyzed the impact of the ingestion of liquid laundry detergent capsules on admission laboratory tests in paediatric patients. Methods This retrospective study was conducted in the clinical toxicology unit of a paediatric poison centre between 2015 and 2021. Paediatric patients (less than 18 years of age) who ingested liquid laundry detergent capsules were included. The relationship between the European Association of Poisons Centers and Clinical Toxicologists/European Commission/International Programme on Chemical Safety Poisoning Severity Score and admission laboratory test results was assessed using Fisher’s exact test or analysis of variance. Results A total of 156 patients were included in the study. A considerable proportion of patients presented with leucocytosis, acidosis, hyperlactataemia or base deficit. The median values of white blood cell count (P = 0.042), pH (P = 0.022), and base excess (P = 0.013) were significantly different among the Poisoning Severity Score groups. Hyperlactataemia was strongly associated with the Poisoning Severity Score (P = 0.003). Discussion Leucocytosis is a non-specific marker of severity following ingestion of liquid laundry detergent capsules. The incidence of metabolic acidosis and hyperlactataemia was higher in this study than in previous reports, but these metabolic features were not related to the severity of exposure. The exact mechanisms of toxicity are not yet known, but the high concentration of non-ionic and anionic surfactants, as well as propylene glycol and ethanol, in the capsule are likely contributing factors. Conclusions Pediatric patients who ingest liquid laundry detergent capsules may develop leucocytosis, metabolic acidosis, hyperlactataemia, and a base deficit.

Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial

ObjectiveDouble-blind randomized control trial of early addition of a bovine milk-derived human milk fortifier (HMF) in very low birth weight (VLBW) infants (NCT05228535).MethodsVLBW infants were randomized to receive bovine milk-derived HMF with first feedings or delayed fortification at 80 ml/kg/day. Anthropometrics were assessed weekly through 36 weeks postmenstrual age (PMA). Unadjusted and adjusted (race, gender, gestational age, and birth weight) differences between study arms were examined using two-sample t-test and ANCOVA, respectively.ResultsFifty-two VLBW infants (57% female, 60% Black) were enrolled. Baseline demographics did not differ between groups. Weight velocity at DOL 28 did not differ between study arms. Secondary outcomes including NPO occurrence, incidence of metabolic acidosis, NEC, retinopathy, or late-onset sepsis did not differ between groups.ConclusionImmediate fortification of enteral feedings with a bovine milk-derived HMF appears safe and well-tolerated although no clear growth benefit could be established.

Association of body mass index with the development of metabolic acidosis in patients with chronic kidney disease.

Higher body mass index (BMI) is associated with higher bone mass and bone serves as a buffer during the development of metabolic acidosis. The authors sought to examine the relationship between BMI and metabolic acidosis in patients with chronic kidney disease (CKD). The study utilized a large US longitudinal data repository including over 103 million patients from healthcare provider organizations to evaluate the relationship between the exposure variable (BMI) and the prevalence and incidence of metabolic acidosis among patients with estimated glomerular filtration rate <60ml/min/1.73m2. Incident metabolic acidosis was identified at the first of two consecutive post-index serum bicarbonate values, 10-365days apart, between 12 and <22 mEq/L in patients with normal index serum bicarbonate. Cox proportional hazard models were adjusted for multiple variables including demographics, comorbidities, income, education, and kidney function. 103,766 patients qualified for this study; 6472 (6.2%) had metabolic acidosis at index. An inverse association between BMI category and metabolic acidosis was observed for both baseline (prevalence) and new-onset (incidence) metabolic acidosis. Compared to BMI category of 18.5 to <25kg/m2, each category of incrementally higher BMI was associated with a decreasing risk of incident metabolic acidosis; the adjusted hazard ratios (95% confidence interval) were 0.866 (0.824-0.911), 0.770 (0.729-0.813), 0.664 (0.622-0.709), and 0.612 (0.571-0.655) for BMI 25 to <30, 30 to <35, 35 to <40, and 40+ kg/m2, respectively. Among patients with CKD, an incremental increase in BMI was inversely associated with both the prevalence and incidence of metabolic acidosis. These associations suggest that increased body weight may protect against the development of metabolic acidosis, a risk factor for progressive loss of kidney function.

#3462 A STUDY OF ETIOLOGY OF ACUTE KIDNEY INJURY AND ACUTE ON CHRONIC KIDNEY DISEASE AMONGST IN-HOSPITAL PATIENTS IN A TERTIARY CARE CENTRE IN INDIA

Abstract Background and Aims Acute kidney injury (AKI) is the leading cause of nephrology consultation and is associated with high mortality rates. The primary causes of AKI include sepsis, ischemia, hypoxia or nephrotoxicity. An underlying feature is a rapid decline in GFR usually associated with a decrease in renal blood flow. Inflammation represents an important additional component of AKI leading to the extension phase of injury, which may be associated with insensitivity to vasodilator therapy. Recent data suggest that AKI represents a potential link to chronic kidney disease (CKD) in surviving patients. Patients with CKD may be at risk for the development of a transient decrease in renal function consistent with AKI. Such rapidly declining renal function causing an acute deterioration of CKD is termed acute-on-chronic kidney disease (ACKD). The mechanisms by which these occur include failure of auto-regulation, abnormal vasodilatation, susceptibility to antihypertensive agents &amp; side effects of medication. The successful recovery from AKI depends on the degree to which these repair processes ensue &amp; these may be compromised in elderly or CKD patients. Aim To determine the burden of AKI among the in-hospital patients &amp; their progression to CKD if at all along with the number &amp; cause of the cases of CKD who develop ACKD due to an acute insult. Method The first 100 consecutive patients admitted with Acute Kidney Injury and Acute on Chronic Kidney Disease in the Department of General Medicine, Nephrology, Intensive care unit in KPC Medical College &amp; Hospital, Kolkata, were selected for the study. Inclusion criteria: • Patients admitted with AKI, ACKD or developing them during the course of stay. • CKD stages I to V with acute exacerbation (reduced GFR, reduced urine output). Exclusion criteria: • Patients &amp;lt;14 years • ESRD patients already on hemodialysis. • Patients with acute Glomerulonephritis (due to the unavailability of biopsy in our institution) • Patients not giving consent to participate in the study. For statistical analysis, data were entered into a Microsoft excel spreadsheet and then analyzed by SPSS and GraphPad Prism version 5. Data had been summarized as mean and standard deviation for numerical variables and count and percentages for categorical variables. Unpaired proportions were compared by Chi-square test or Fischer's exact test, as appropriate. p-value ≤ 0.05 was considered statistically significant. Results ● Out of the first 100 consecutive patients fulfilling the study criteria, 33 patients had AKI &amp; 15 patients had ACKD. ● The male population was higher than the female population. ● T2DM and HTN were more common in ACKD patients than the AKI patients. ● Patients with AKI were clinically dehydrated compared to patients with ACKD. ● Metabolic acidosis was less in AKI patients. ● Most of the ACKD patients had sepsis than the AKI patients. Conclusion The most common etiology of AKI amongst in-hospital patients is dehydration whereas that of ACKD is sepsis associated with more incidence of metabolic acidosis &amp; comorbidities. Earlier diagnosis of AKI represents an important area in treating patients with AKI that has spawned increased awareness of the potential that biomarkers of AKI may play in the future.

Early versus late parenteral nutrition in term and late preterm infants: study protocol for a randomised controlled trial

BackgroundDespite the wide use of parenteral nutrition (PN) in neonatal intensive care units (NICU), there is limited evidence regarding the optimal time to commence PN in term and late preterm infants. The recommendations from the recently published ESPGHAN/ESPEN/ESPR/CPEN and NICE guidelines are substantially different in this area, and surveys have reported variations in clinical practice. The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of early versus late PN in term and late preterm infants.Methods/designThis study is a single-centre, non-blinded RCT in the NICU of Perth Children’s Hospital, Western Australia.A total of 60 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 3-5 days will be randomised to early (day 1 or day 2 of admission) or late commencement (day 6 of admission) of PN after informed parental consent. In both groups, EN will be commenced as early as clinically feasible. Primary outcomes are plasma phenylalanine and plasma F2-isoprostane levels on Day 4 and Day 8 of admission. Secondary outcomes are total and individual plasma amino acid profiles, plasma and red blood cell fatty acid profiles, in-hospital all-cause mortality, hospital-acquired infections, length of hospital/NICU stay, z scores and changes in z scores at discharge for weight, height and head circumference, time to full EN, duration of respiratory (mechanical, non-invasive) support, duration of inotropic support, the incidence of hyper and hypoglycaemia, incidence of metabolic acidosis, liver function, blood urea nitrogen, and C-reactive protein (CRP).DiscussionThis RCT will examine the effects of early versus late PN in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to the timing of commencement of PN in such infants.Trial registrationANZCTR; ACTRN12620000324910 (3rd March 2020)

Metabolic acidosis in the initial 6months after renal transplantation: A prospective study.

There is limited information about the incidence of metabolic acidosis (MA) after renal transplantation. This single centre prospective study aimed to delineate the incidence and risk factors of MA in the first 6months after renal transplantation (RTX). Patients who underwent RTX between November 2018 and July 2020 were monitored with weekly measurement of serum bicarbonate level for 6months and those who were diagnosed with MA were evaluated further to characterize the type of MA. One hundred and twenty-five patients were included in the study, 89 (71.2%) of whom developed MA. Seventy-two patients developed MA in the first month, 11 during the 2-3months and 6 between 4 and 6months after transplantation. Of the 89 patients, 55(61.8%) had type 1 renal tubular acidosis (T1RTA), 27 (30.3%) had type 2 RTA (T2RTA) and 7 (7.9%) type 4 RTA (T4RTA). Two patient who had T1RTA, subsequently developed high anion gap MA following severe graft rejection. On stepwise multivariate regression analysis, serum creatinine at time of diagnosis of MA [OR (95% CI): 12.02 (1.79 to 80.59), p=.01] and high tacrolimus C0 levels [OR (95% CI): 2.43 (1.0 to 5.90), p=.049], were independent risk factors for MA. There is a high incidence of MA in the initial 6months post-transplant with serum creatinine and high tacrolimus C0 levels being independent risk factors.

Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial

IntroductionSepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for...

Metabolic Acidosis in the Surgical Intensive Care Unit: Risk Factors, Clinical Correlates and Outcome. Findings from a High Dependency Heart and Vascular Surgical Center in Nigeria

Background: Metabolic acidosis (MA) is a common finding on the surgical ward, more so in the intensive care unit. Diseases affecting the major organ systems of the body and higher grades of surgery are common risk factors for MA. It is associated with poor treatment outcome. Aim: To determine the risk factors and clinical correlates of metabolic acidosis and assess its relationship with treatment outcome. Methodology: A retrospective study at the “Tristate Heart and vascular Center” in Ilishan-Remo South west Nigeria, on patients that had cardiac and vascular surgeries from January 2015 to December 2019. Three hundred and forty two participants took part in the study. The demographic, clinical and laboratory findings were entered. Statistical analysis was with Student’s t-test and Chi square. Results: Two hundred and six males and 136 females were studied. The incidences of metabolic acidosis prior to induction, on post-operative day one (POD1) and on POD28 were 20.7%, 39.8% and 14.1% respectively. Nine (2.6%) participants died during admission, of this, 6 (66.7%) had MA at presentation but all (100%) had MA on POD1. The Risk factors for MA were advanced age, comorbidities, open heart surgery, elevated systolic blood pressure and low eGFR. Metabolic acidosis was a risk factor for prolonged hospital stay, perioperative death and declining kidney function which was commoner among participants with preexisting kidney dysfunction. Conclusion: The incidence of metabolic acidosis was 20.7% at induction of anesthesia, rose to 39.8% on POD1 and by POD28, it has significantly reduced to 14.1%. While advancing age and comorbidities were risk factors for MA, the occurrence of MA increased the risk of declining kidney function, prolonged hospital stay and death.

Fetal ST baseline T/QRS rise in normal CTG does not predict neonatal acidemia

Purpose Analysis of the ST segment of the fetal electrocardiogram (ECG) waveform is a relatively new adjunct to support the cardiotocograph in assessing the risk of significant intrapartum fetal acidosis. The use of ST analysis (STAN) combined with cardiotocography (CTG) was reported to significantly lower the incidence of metabolic acidosis. We aimed to assess the role of “baseline T/QRS rise” associated with a normal CTG on the risk of neonatal acidemia. Study design This is a prospective cohort study performed at the Division of Perinatal Medicine of Policlinico Abano Terme, Italy. Women in labor with a singleton fetus in cephalic position beyond 36 weeks of gestation were monitored with STAN and CTG. Patients and methods The relationship between “baseline T/QRS rise” and neonatal cord arterial acidemia and hypoxic distress were assessed using a linear mixed-model analysis. Magnitude of “baseline T/QRS rise”, neonatal cord blood acidemia, electrolytes, lactacidemia, and glycemia levels were measured. Results “Baseline T/QRS rise” was not associated with neonatal acidemia in the presence of normal CTG, regardless of the magnitude of the T/QRS rise. However, in a linear mixed-model analysis, cord blood sodium levels were negatively (p = .033) associated with T/QRS ratio magnitude. Conclusions In the presence of a normal CTG, “baseline T/QRS rise” does not predict neonatal acidemia or biochemical derangement. Greater knowledge of fetal ECG parameters including “baseline T/QRS rise” and their associations with normal, intermediary, and abnormal CTG tracing, is required in assessing the performance of the STAN.

The evaluation of the relationship between serum levels of Interleukin-6 and Interleukin-10 and metabolic acidosis in hemodialysis patients.

Chronic kidney disease is defined as progressive kidney dysfunction. The levels of various cytokines increase in hemodialysis (HD) patients. High levels of interleukins (ILs) and presence of metabolic acidosis are described as independent risk factors for morbidity and mortality in these patients. This study was designed to evaluate the relationship between IL-6 and IL-10 and serum bicarbonate and metabolic acidosis in HD patients. In this analytical crosssectional study, patients referred to the HD units of Loghman Hakim and Shahid Ashrafi Esfahani Hospitals were randomly selected. Demographic and laboratory data, such as albumin, creatinine, calcium, phosphorus, parathormone, C-reactive protein, complete blood count, ferritin, ILs-6 and -10, and arterial blood gas analysis, were recorded for each patient. The correlation between IL and serum bicarbonate and other variables were evaluated by SPSS software. The patients were compared for the presence of acidosis and positivity for IL. A total of 84 patients with a mean age of 60.98 years and mean body mass index of 24.86 kg/m[2] were evaluated (53% male and 57% female). The mean dialysis duration was 24.86 ± 3.98 months. Overall, 41.7% of the patients had diabetes mellitus and 36.9% of them had hypotension. The mean serum levels of IL-6 and IL-10 were 6.036 and 17.46 pg/ml, respectively. There was a significant correlation between IL-6 and IL-10 levels and serum bicarbonate and the incidence of metabolic acidosis (P <0.05). Based on the results, metabolic acidosis and bicarbonate could be considered prognostic factors to differentiate the increased levels of IL-6 and IL-10 and associated morbidity and mortality.

Is There a Role for Balanced Solutions in Septic Patients?

The use of fluid bolus infusion is the cornerstone for hemodynamic resuscitation of critically ill patients. Recently, the clinical use of colloids has lost strength with the publication of several trials suggesting no benefit, and possible harm of its use.On the other hand, the so-called balanced solutions, with low chloride concentrations, have emerged as an alternative with potential physiological benefits over traditional saline solution. Normal saline carries a high amount of chloride which has been associated with an increased incidence of metabolic acidosis, renal vasoconstriction, and reduced urine output. Recent observational studies associated the use of saline with acute kidney injury, which was not observed in a single prospective randomized controlled trial.The present review summarizes available literature regarding the potential clinical and laboratorial benefits of balanced solutions in septic patients.

An acetate-buffered balanced crystalloid versus 0.9% saline in patients with end-stage renal disease undergoing cadaveric renal transplantation: a prospective randomized controlled trial.

Recent studies have shown a decline in glomerular filtration rate and increased renal vasoconstriction after administration of normal saline when compared with IV solutions with less chloride. In this study, we investigated the impact of normal saline versus a chloride-reduced, acetate-buffered crystalloid on the incidence of hyperkalemia during cadaveric renal transplantation. The incidence of metabolic acidosis and kidney function were secondary aims. In this prospective randomized controlled trial, 150 patients received normal saline or an acetate-buffered balanced crystalloid during and after cadaveric renal transplantation. Venous blood gases were obtained at the start of anesthesia and every 30 minutes until discharge from the postoperative surveillance unit. Serum creatinine and 24-hour urine output were obtained on postoperative days 1, 3, and 7. Patients received a similar amount of fluid (median: 2625mL [interquartile range: 2000 to 3100] vs 2500 mL [2000 to 3050], P = 0.83). Hyperkalemia, defined as serum potassium >5.9 mmol/L, occurred in 13 patients (17%) in the saline and 15 (21%) in the balanced group (P = 0.56; difference between proportions -0.037 [-16.5% to 8.9%]). Minimum base excess was lower in the saline group compared with the balanced regimen (-4.5 mmol/L [-6 to -2.4] vs -2.6 mmol/L [-4 to -1], P < 0.001) and maximum chloride was significantly higher in the saline group (109 mmol/L [107 to 111] vs 107 mmol/L [105 to 109], P < 0.001). No difference in creatinine or urine output was seen postoperatively. Significantly more patients needed catecholamines in the saline group (30% vs 15%, P = 0.03). The incidence of hyperkalemia differed by less than 17% between groups. Use of balanced crystalloid resulted in less hyperchloremia and metabolic acidosis. Significantly more patients in the saline group required administration of catecholamines for circulatory support.

Development of Metabolic Acidosis after Neobladder Reconstruction

Objectives: Metabolic acidosis frequently develops in patients after neobladder reconstruction. However, the incidence of metabolic acidosis in patients with neobladder and the factors associated with the development of metabolic acidosis have not been well elucidated. We aimed to investigate the incidence and the potential predictors for the development of metabolic acidosis after neobladder reconstruction with intestinal segment. Methods: We included patients who underwent neobladder reconstruction using intestinal segment at Ewha Womans University Mokdong Hospital between January 1, 2005 and December 31, 2014. A subgroup of patients according to the time of metabolic acidosis occurrence was further analyzed in order to characterize predictors for metabolic acidosis. Results: Metabolic acidosis was encountered in 79.4% of patients with neobladder during follow up period. When patients were divided into 2 groups according to anion gap (AG), total CO2 (18.9±2.1 mEq/L vs. 20.0±1.3 mEq/L, P=0.001) and chloride (106.6±4.9 mE/L vs. 109.4±3.6 mEq/L, P 12 and AG≤12. Furthermore, when patients were divided into 3 groups; patients with metabolic acidosis at postoperative day (POD) 1; from POD 2 to 14 days; after 14 days, there was significant difference among those subgroups. Conclusion: Our study showed the rate of metabolic acidosis in patients underwent neobladder reconstruction and the difference between patients with metabolic acidosis and those without metabolic acidosis for the first time in Korea. In the future, well designed prospective study will be needed to prevent metabolic acidosis after neobladder reconstruction. (Ewha Med J 2015;38(3):98-105) Received May 6, 2015 Accepted July 2, 2015

Propofol infusion associated metabolic acidosis in patients undergoing neurosurgical anesthesia: a retrospective study.

ObjectivePropofol and volatile anesthesia have been associated with metabolic acidosis induced by increased lactate. This study was designed to evaluate changes in pH, base excess (BE), and lactate in response to different anesthetic agents and to characterize propofol infusion-associated lactic acidosis.MethodsThe medical records of patients undergoing neurosurgical anesthesia between January 2005 and September 2012 were examined. Patients were divided into 2 groups : those who received propofol (total intravenous anesthesia, TIVA) and those who received sevoflurane (balanced inhalation anesthesia, BIA) anesthesia. Propensity analysis was performed (1 : 1 match, n=47), and the characteristics of the patients who developed severe acidosis were recorded.ResultsIn the matched TIVA and BIA groups, the incidence of metabolic acidosis (11% vs. 13%, p=1) and base excess (p>0.05) were similar. All patients in the TIVA group who developed severe acidosis did so within 4 hours of the initiation of propofol infusion, and these patients improved when propofol was discontinued.ConclusionsThe incidence of metabolic acidosis was similar during neurosurgical anesthesia with propofol or sevoflurane. In addition, severe acidosis associated with propofol infusion appears to be reversible when propofol is discontinued.

ST Analysis of the Fetal Electrocardiogram in Intrapartum Fetal Monitoring

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A randomised clinical trial on cardiotocography plus fetal blood sampling versus cardiotocography plus ST-analysis of the fetal electrocardiogram (STAN®) for intrapartum monitoring

BackgroundCardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive test results and without fetal blood sampling (FBS), it results in an increase in operative deliveries without improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two clinical trials have shown that a combination of CTG and ST-analysis of the fetal electrocardiogram (ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both trials FBS was still performed in the ST-analysis arm, and it is therefore still unknown if the observed results were indeed due to the ST-analysis or to the use of FBS in combination with ST-analysis.Methods/DesignWe aim to evaluate the effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in a multicentre randomised clinical trial setting. Secondary aims are: 1) to judge whether ST-analysis of fetal electrocardiogram can significantly decrease frequency of performance of FBS or even replace it; 2) perform a cost analysis to establish the economic impact of the two treatment options.Women in labour with a gestational age ≥ 36 weeks and an indication for CTG-monitoring can be included in the trial.Eligible women will be randomised for fetal surveillance with CTG and, if necessary, FBS or CTG combined with ST-analysis of the fetal ECG.The primary outcome of the study is the incidence of serious metabolic acidosis (defined as pH < 7.05 and Bdecf > 12 mmol/L in the umbilical cord artery). Secondary outcome measures are: instrumental delivery, neonatal outcome (Apgar score, admission to a neonatal ward), incidence of performance of FBS in both arms and cost-effectiveness of both monitoring strategies across hospitals.The analysis will follow the intention to treat principle. The incidence of metabolic acidosis will be compared across both groups. Assuming a reduction of metabolic acidosis from 3.5% to 2.1 %, using a two-sided test with an alpha of 0.05 and a power of 0.80, in favour of CTG plus ST-analysis, about 5100 women have to be randomised. Furthermore, the cost-effectiveness of CTG and ST-analysis as compared to CTG and FBS will be studied.DiscussionThis study will provide data about the use of intrapartum ST-analysis with a strict protocol for performance of FBS to limit its incidence. We aim to clarify to what extent intrapartum ST-analysis can be used without the performance of FBS and in which cases FBS is still needed.Trial Registration NumberISRCTN95732366

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A comparison of intrapartum automated fetal electrocardiography and conventional cardiotocography—a randomised controlled study

Sir, We read with great interest the article by Ojala et al.1 The authors report that the incidence of metabolic acidosis after intrapartum monitoring by means of cardiotocography (CTG) supplemented by automatic ST analysis (STAN) of the fetal electrocardiogram is 1.7%, as compared with 0.7% after CTG alone. We wish to comment on the conclusion of the authors that CTG + STAN did not improve the neonatal outcome or decrease the caesarean section rate but that the need for fetal blood sampling (FBS) during labour was lower in the STAN group. In fact, although not statistically significant, there is a clinically relevant difference of 1% in the incidence of metabolic acidosis in favour of the CTG-alone group (metabolic acidosis being defined as a pH < 7.05 and base excess < –12 mmol/l). This is worrying because if confirmed in a larger study, such a difference could result in a poorer neonatal outcome. This finding contrasts with that of the previous study of AmerWahlin.2 Because of the importance of this outcome, we consider that the study was underpowered. Ojala et al. based their power calculation on the incidence of a neonatal umbilical artery pH < 7.10 rather than a pH < 7.05, which is more stringent and relevant to outcome. When using the lower cutoff level in pH, the incidence of neonatal acidaemia will be lower and the required sample size will therefore be higher. In general, the power of a study must be based on the primary endpoint, and this endpoint should be the same in both the power calculation and the final analysis. Second, although again not statistically significant, there is a 1.7% lower overall caesarean section rate in the CTG group. Little attention is paid to this important finding. No information is available about the rate of caesarean sections performed for failure to progress or a combination of failure to progress and fetal distress. It may be that the indications for caesarean section were significantly different in the two groups. In summary, we feel that the study of Ojala et al. raises concerns about fetal outcome when using STAN. In view of this concern, we have started a randomised clinical trial comparing CTG + STAN with CTG + FBS, with a larger sample size. j